Control of Blood Loss During Caesarean Section

A Randomized Trial to Determine the Best Strategy for the Control of Blood Loss at Elective Caesarean Section

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01412073

Enrollment

600

Registered

2011-08-08

Start date

2011-09-30

Completion date

2014-10-31

Last updated

2014-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complications; Cesarean Section

Keywords

caesarean section, intrapartum haemorrhage

Brief summary

trial of 3 protocols to determine the best one to control blood loss during caesarean section

Detailed description

The study population will be divided into 3 groups each containing 200 women: Group (A): 200 patients will receive 5-IU oxytocin bolus over 3 minutes after delivery of the baby. Group (B): 200 patients will receive 5-IU oxytocin bolus over 3 minutes and 30-IU oxytocin infusion in 500 ml 0.9 % saline over 4 hours after delivery of the baby. Group (C): 200 patients will receive misoprostol 800 micrograms intrauterine, placed manually on the bottom of the uterine cavity after delivery of the placenta and cleaning of the cavity. Operative blood loss will be estimated in theatre based on the volume in the suction bottle and the weight of swabs used. We will record blood loss up until the time the woman will be discharged from the theatre recovery ward. Hemoglobin level and haematocrit value will be done as follow:- 1. After admission of each case in the pre-operative period. 2. Immediately post- operative. 3. 24 hours post- operative.

Interventions

DRUGoxytocin

group I : oxytocin 5 IU bolus over 3 minutes after delivery of the baby group II : oxytocin 5 IU bolus over 3 minutes after delivery of the baby and oxytocin infusion in 500 ml 0.9% saline over 4 hours

DRUGMisoprostol

misoprostol intrauterine 800 microgram placed intrauterine after delivery of the baby & the placenta

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

25 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

* Patients booked for elective cesarean section. * Singleton pregnancies. * Primigravida or multipara ,first cesarean section or previous .

Exclusion criteria

* Patients with obstetric hemorrhage. * Uterine laceration. * Placenta previa. * Blood dyscrasias. * Large fibroids. * Multiple pregnancy. * Pre-eclampsia. * Marked maternal anemia. * Previous history of PPH.

Design outcomes

Primary

Measure	Time frame
amount of blood loss	12 month

Secondary

Measure	Time frame
Haemoglobin % and haematocrit value	12 month

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026